Effects of hypertonic saline-hydroxyethylstarch solution on extracellular water in cardiac surgery patients
- Conditions
- MedDRA version: 12.1Level: LLTClassification code 10011078Term: Coronary artery diseaseFifty adult male patients undergoing coronary bypass surgery will be enrolled in this study. Inclusion criteria are male gender and no need for pulmonary artery catheter (pulmonary hypertension or left ventricular ejection fraction < 40%). Exclusion criterion is chronic hyponatremia and significant renal dysfunction.
- Registration Number
- EUCTR2010-019352-42-FI
- Lead Sponsor
- Heart Center Co. Tampere University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 50
Inclusion Criteria
Fifty adult male patients undergoing coronary bypass surgery will be enrolled in this study. Inclusion criteria are male gender and no need for pulmonary artery catheter (pulmonary hypertension or left ventricular ejection fraction < 40%).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Exclusion criterion is chronic hyponatremia and significant renal dysfunction.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning. ;Secondary Objective: Secondary endpoints are the need of fluids and diuretic medication during the perioperative period.;Primary end point(s): Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning.
- Secondary Outcome Measures
Name Time Method